Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity (Pro-MEGA)

The aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery. The main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with MAG-DHA or with the placebo.

Study Overview

• Status: Unknown
• Conditions: PPROM
• Intervention / Treatment: Dietary supplement: MAG-DHA; Dietary supplement: Oleic acid

Detailed Description

This randomized controlled trial will be conducted in two hospitals in the province of Quebec (CHUS, CHUQ- Site mère-enfant Soleil).

Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes (PPROM) who meet all inclusion and none of the exclusion criteria will be approached to participate. Once they have signed the IFC, participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks (14 days). A total of 70 patients will be recruited.

Principal outcome: To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo.

Secondary outcomes: 1) Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group. 2) Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo.

This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Belle Poirier, PhD; Phone Number: 12865 8193461110; Email: Marie-Belle.Poirier@USherbrooke.ca
• Study Contact Backup: Name: Eric Rousseau, PhD; Phone Number: 75306 819-346-1110; Email: eric-rousseau@usherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.

Exclusion Criteria:

• multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAG-DHA; 1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks	Dietary supplement: MAG-DHA; 375 MG of MAG-DHA per capsules, two capsules BID; Other Names: Pro-omega-3
Placebo Comparator: Placebo; 1500 MG of oleic acid per day until childbirth or for up to 2 weeks	Dietary supplement: Oleic acid; 375 MG of sunflower oil (oleic acid) per capsules, two capsules BID; Other Names: Sunflower oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration latency period	From PPROM through delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite neonatal score	Composite neonatal score includes any one or more of the following: acute respiratory distress, bronchopulmonary dysplasia, proven sepsis, necrotizing enterocolitis, severe intraventricular hemorrhage (grade> 2) or periventricular leukomalacia	From birth through the first 28 days of life
Inflammatory status	Inflammatory status will be determined based on the quantification of any one or more of the following biomarkers in blood and vaginal secretions specimens: resolvins, lipoxygenase isoforms	Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Laval University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 3, 2018
• Primary Completion (Anticipated): November 5, 2019
• Study Completion (Anticipated): May 15, 2020

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Prematurity; Pro-omega-3
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Inflammation; Premature Birth
• Other Study ID Numbers: MP-31-2018-2496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No